Transcatheter Aortic Valve Replacement - Centers for Medicare & Medicaid Services

Transcatheter Aortic Valve Replacement - Centers for Medicare & Medicaid Services

Coverage with Evidence Development

Transcatheter Aortic Valve Replacement
     Added clinical study approval
https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/TAVR.html

Transcatheter Aortic Valve Replacement

Transcatheter aortic valve replacement (TAVR - also known as TAVI or transcatheter aortic valve implantation) is a new technology for use in treating aortic stenosis. A bioprosthetic valve is inserted percutaneously using a catheter and implanted in the orifice of the native aortic valve.

CMS issued a Medicare National Coverage Determination on May 1, 2012 which allows coverage of TAVR under Coverage with Evidence Development (CED) with certain conditions.  The complete determination is available on our website.  As part of CED, we are identifying below the Medicare approved registry and Medicare approved clinical trials which have been reviewed and determined to meet the requirements of coverage.

http://www.cms.gov//medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=257

Registry Approvals

STS/ACC Transcatheter Valve Therapy (TVT) Registry
ClinicalTrials.gov number: NCT01737528
https://www.ncdr.com/TVT/Home/Default.aspx